Bydureon

"The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

PATIENT INFORMATION

Read this Medication Guide before you start using
BYDUREON and each time you get a refill. There may be new information. This
information does not take the place of talking with your healthcare provider
about your medical condition or your treatment.

What is the most important information I should know
about BYDUREON?

Serious side effects may happen in people who use
BYDUREON, including:

1. Possible thyroid tumors, including cancer.
During the drug testing process, the medicine in BYDUREON caused rats to
develop tumors of the thyroid gland. Some of these tumors were cancers. It is
not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer
called medullary thyroid cancer in people.

Before you start using BYDUREON, tell your healthcare
provider if you or any of your family members have had thyroid cancer,
especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome
type 2. Do not use BYDUREON if you or any of your family members have medullary
thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2.
People with these conditions already have a higher chance of developing
medullary thyroid cancer in general and should not use BYDUREON.

While using BYDUREON, tell your healthcare provider if
you get a lump or swelling in your neck, hoarseness, trouble swallowing, or
shortness of breath. These may be symptoms of thyroid cancer.

2. Inflammation of the pancreas (pancreatitis), which
may be severe and lead to death.

These medical conditions can make you more likely to get
pancreatitis. It is not known if having these conditions will lead to a higher
chance of getting pancreatitis while taking BYDUREON.

Stop using BYDUREON and call your healthcare provider
right away if you have pain in your stomach area (abdomen) that is severe,
and will not go away. The pain may happen with or without vomiting. The pain
may be felt going from your abdomen through to your back. This type of pain may
be a symptom of pancreatitis.

What is BYDUREON?

BYDUREON is an injectable prescription medicine that may
improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and
should be used along with diet and exercise.

BYDUREON is a long-acting form of the medication
contained in BYETTA. Do not use BYDUREON and BYETTA together.

BYDUREON is not recommended as the first choice of
medication for treating diabetes.

It is not known if BYDUREON is safe and effective in
children. BYDUREON is not recommended for use in children.

It is not known if BYDUREON is safe and effective in
people who have a history of pancreatitis.

BYDUREON has not been studied in people who have severe
kidney problems.

Who should not use BYDUREON?

Do not use BYDUREON if:

you or any of your family members have a history of
medullary thyroid cancer.

you have Multiple Endocrine Neoplasia syndrome type 2
(MEN 2). This is a disease where people have tumors in more than one gland in
their body.

you are allergic to exenatide or any of the ingredients
in BYDUREON. See the end of this Medication Guide for a complete list of
ingredients in BYDUREON. Symptoms of a severe allergic reaction may include:

Talk to your healthcare provider before using this
medicine if you have any of these conditions.

What should I tell my healthcare provider before using
BYDUREON?

Before using BYDUREON, tell your healthcare provider
if you:

have any of the conditions listed in the section “What
is the most important information I should know about BYDUREON?”

have severe problems with your stomach such as slow
emptying of your stomach (gastroparesis) or problems digesting food.

have or have had kidney problems, or have had a kidney
transplant.

have any other medical conditions.

are pregnant or are planning to become pregnant. It is
not known if BYDUREON may harm your unborn baby. Tell your healthcare provider
if you become pregnant while taking BYDUREON. Pregnancy Registry: There is a registry for women who use BYDUREON
during pregnancy. The purpose of this registry is to collect information about
the health of you and your baby. If you use BYDUREON at any time during
pregnancy, you may enroll in this registry by calling 1-800-633-9081.

are breastfeeding or plan to breastfeed. It is not known
if BYDUREON passes into your breast milk. You and your healthcare provider
should decide if you will use BYDUREON or breastfeed. You should not do both
without talking with your healthcare provider first.

Tell your healthcare provider about all of the
medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. BYDUREON may affect the way some medicines
work and some other medicines may affect the way BYDUREON works.

Know the medicines you take. Keep a list of them to show
your healthcare provider and pharmacist each time you get a new medicine.

How should I use BYDUREON?

For detailed instructions, see the Instructions for
Use that comes with your BYDUREON.

BYDUREON comes as a single-dose tray or as a single-dose
pen. Your healthcare provider will prescribe the BYDUREON that is best for you.

Your healthcare provider should teach you how to use
BYDUREON before you use it for the first time. If you have any questions or
do not understand the instructions, talk with your healthcare provider or
pharmacist.

Pay special attention to mixing BYDUREON well, as shown
in the Instructions for Use.

After injecting with the BYDUREON Pen, make sure you hold
the needle in your skin for 10 seconds, to get the full dose.

Use BYDUREON exactly as your healthcare provider tells
you to.

BYDUREON is injected once every seven days (weekly) any
time during the day.

BYDUREON is a subcutaneous injection. Inject BYDUREON
into your skin exactly the way your healthcare provider told you to. You can
use the injection in your stomach area (abdomen), your thigh, or the back of
your upper arm. Each week you can use the same area of your body. But be sure
to choose a different injection site in that area.

You can use BYDUREON with or without food.

If you miss a dose of BYDUREON, it should be used as
soon as you remember, provided the next regularly scheduled dose is due at
least 3 days later.

If you miss a dose of BYDUREON and the next regularly
scheduled dose is due 1 or 2 days later, do not use the missed dose. Use
BYDUREON on the next regularly scheduled day.

Do not use 2 doses of BYDUREON less than 3 days
apart.

If you want to change your dosing day, you can. Your new
dosing day must be at least 3 days after your last dose.

BYDUREON must be injected right after you mix it.

If you are taking BYETTA and your healthcare provider
prescribed BYDUREON, you should follow your healthcare provider's instructions
about when to stop taking BYETTA and when to start taking BYDUREON. BYETTA
is a different form of the same medicine that is in BYDUREON, so do not take
BYETTA when you are taking BYDUREON. When you first change from BYETTA to
BYDUREON, your blood sugar levels may be higher than usual and should get
better in about 2 weeks.

Inject your dose of BYDUREON under the skin (subcutaneous
injection), as you are told to by your healthcare provider. Do not inject
BYDUREON into a vein or muscle.

Do not share your BYDUREON with another person
even if the needle is changed. Sharing your tray or pen with another person can
cause you or someone else to get an infection.

Follow your healthcare provider's instructions for diet,
exercise, how often to test your blood sugar, and when to get your HbA1c checked.
If you see your blood sugar increasing during treatment with BYDUREON, talk to
your healthcare provider because you may need to adjust your current treatment
plan for your diabetes.

Talk to your healthcare provider about how to manage high
blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to
recognize problems that can happen with your diabetes.

What are the possible side effects of BYDUREON?

BYDUREON can cause serious side effects, including:

See “What is the most important information I should
know about BYDUREON?”

Low blood sugar (hypoglycemia). Your risk for
getting low blood sugar is higher if you use BYDUREON with another medicine
that can cause low blood sugar, such as a sulfonylurea. The dose of your
sulfonylurea medicine may need to be lowered while you use BYDUREON. Signs and
symptoms of low blood sugar may include:

shakiness

sweating

headache

irritability

drowsiness

hunger

weakness

fast heartbeat

dizziness

feeling jittery

confusion

Kidney problems (kidney failure). BYDUREON may
cause nausea, vomiting or diarrhea leading to loss of fluids (dehydration).
Dehydration may cause kidney failure, which can lead to the need for dialysis.
This can happen in people who have never had kidney problems before. Drinking
plenty of fluids may reduce your chance of dehydration. Call your healthcare
provider right away if you have nausea, vomiting, or diarrhea that will not go
away, or if you cannot drink liquids by mouth.

Severe allergic reactions. Severe allergic
reactions can happen with BYDUREON. Stop using BYDUREON, and get medical help
right away if you have any symptom of a severe allergic reaction. See “Who
should not use BYDUREON?”

Injection-site reactions. Serious injection-site
reactions, with or without bumps (nodules), have happened in some people who
use BYDUREON. Some of these injection-site reactions have required surgical
intervention. Call your healthcare provider right away if you have any of the
following at your injection site:

Nausea is most common when you first start using
BYDUREON, but decreases over time in most people as their body gets used to the
medicine.

Talk to your healthcare provider about any side effect
that bothers you or does not go away.

These are not all the side effects of BYDUREON. For more
information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.

How should I store BYDUREON?

Store BYDUREON in the refrigerator at 36°F to 46°F (2°C
to 8°C).

Do not use BYDUREON past the expiration date
printed on the BYDUREON carton, single-dose tray cover, or pen label. The
expiration date is labeled EXP and can be found on the paper cover of the
single-dose tray or single-dose pen.

Do not freeze BYDUREON. Do not use BYDUREON
if it has been frozen.

Keep BYDUREON within its sealed tray until ready for use.

Protect BYDUREON from light until you are ready to
prepare and use your dose.

If needed, you can keep BYDUREON single-dose tray out of
the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.

See the Instructions for Use for information about how to
throw away your used BYDUREON parts.

Keep BYDUREON, and all medicines, out of the reach of
children.

General information about safe and effective use of
BYDUREON

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use BYDUREON for a condition
for which it was not prescribed. Do not give your BYDUREON to other people,
even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important
information about BYDUREON. If you would like more information, talk with your
healthcare provider. You can ask your healthcare provider or pharmacist for
information about BYDUREON that is written for healthcare professionals.

For more information about BYDUREON, go to www.BYDUREON.com
or call 1-877-700-7365.

Before using Bydureon, your healthcare provider should
show you how to use it the right way.

Read these Instructions for Use before you start using
BYDUREON Single-Dose Tray and each time you get a refill. There may be new
information. This information does not take the place of talking to your
healthcare provider about your medical condition or your treatment.

Getting ready

Never share your BYDUREON vials or needles with anyone
else. You may give an infection to them or get an infection from them.

BYDUREON Single-Dose Tray is not for self-injection by
people who are blind or cannot see well.

sharps container for throwing away used needles, vials,
and syringes. See Step 4h “Disposing of used Needles and Syringes.”

Your guide to your BYDUREON Single-Dose Tray

Single-dose tray

Keep this flap open so you
can refer to it as you go through the steps.

Your guide to the parts

Single-dose tray

What's Inside

To take the correct dose, read each
page so that you do every step in order.

This step-by-step guide is
divided into 4 sections:

Getting Started

Connecting the Parts

Mixing the Medicine and Filling
the Syringe

Injecting the Medicine

For Common Questions and
Answers, see page X.

How to store your
Single-Dose Trays of BYDUREON

Store your BYDUREON trays in
the refrigerator at 36°F to 46°F (2°C to 8°C).

If needed, you can keep your
BYDUREON tray out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to
4 weeks.

Protect BYDUREON from light
until you are ready to prepare and use your dose.

Do not freeze BYDUREON trays.

Do not use BYDUREON past the
expiration date. The expiration date is labeled EXP and can be found on the
paper cover of each tray.

Keep BYDUREON, and all
medicines, out of the reach of children.

1. Getting Started

1a) Take a Single-Dose Tray
from the refrigerator.

1b) Wash your hands. Prepare to clean your
injection site with soap and water or an alcohol swab prior to injecting your
medicine.

Peel back the paper cover to open.

Remove the syringe. The liquid in the syringe should be
clear with no particles in it. It is okay if there are bubbles.

Place the needle, vial connector package, vial, and
syringe on a clean, flat surface.

Pick up the needle, and
twist off the blue cap.

Set the covered needle aside.
You will use it later.

There is a spare needle in the
tray if you need it.

Pick up the vial.

Tap the vial several times
against a hard surface to loosen the powder.

Use your thumb to remove the
green cap.

Put the vial aside.

2. Connecting the Parts

Pick up the vial connector
package and peel off the paper cover. Do not touch the orange connector inside.

Hold the vial connector package. In your other hand,
hold the vial.

Press the top of the vial
firmly into the orange connector.

Then lift the vial with the
orange connector now attached out of the clear package.

This is what the vial should
now look like.

Put it aside for later.

Pick up the syringe.

With your other hand, firmly
grasp the 2 gray squares on the white cap.

Break off the cap.

Be careful not to push in the plunger.

Just like you might break a
stick, you are breaking off the cap.

This is what the broken-off
cap looks like.

You will not be using the cap
and can throw it away.

This is what the syringe
should now look like.

Now, pick up the vial with
the orange connector attached.

Twist the orange connector
onto the syringe until snug. While twisting, be sure to grasp the orange connector. Do
not over tighten.

This is how the parts should
now look when they are connected.

3. Mixing the Medicine and
Filling the Syringe

IMPORTANT:

During these next steps, you
will be mixing the medicine and filling the syringe. Once you mix the medicine,
you must inject it. You cannot save the mixed medicine to inject at a later
time.

With your thumb, push down the plunger until it stops.

The plunger may feel like it is springing back a little.

For steps 3a to 3f, keep
pushing down on the plunger with your thumb.

Hold the plunger down and
shake hard. Keep shaking until the liquid and powder are mixed well.

The vial will not come off. The
orange connector will keep it attached to the syringe.

Shake hard like you would
shake a bottle of oil-and vinegar salad dressing.

When the medicine is mixed well, it should look
cloudy.

If you see clumps of dry
powder on the sides or bottom of the vial, the medicine is not mixed well.

Shake hard again until well
mixed.

Keep pushing down on the
plunger while shaking.

If you have any questions or
are not sure if your BYDUREON is mixed well, call 1-877-700-7365 for help.

Now, hold the vial upside
down so the syringe is pointing up. Continue to hold the plunger in place with
your thumb.

Gently tap the vial with the
other hand. Continue to hold the plunger in place.

The tapping helps the medicine
drip down. It is okay if there are bubbles.

Pull the plunger down beyond
the black dashed Dose Line.

This draws the medicine from
the vial into the syringe. You may see air bubbles. This is normal.

A little bit of liquid may
cling to the sides of the vial.

With 1 hand, hold the
plunger in place so it does not move.

With the other hand, twist the
orange connector to remove it from the syringe.

Be careful not to push in
the plunger.

This is what the syringe
should now look like.

4. Injecting the Medicine

Pick up the needle. Twist the
needle onto the syringe until snug. Do not remove the needle cover yet.

IMPORTANT:

Read the next steps
carefully and look closely at the pictures. This helps you get the correct dose
of medicine.

Slowly push in the plunger
so the top of the plunger lines up with the black dashed Dose Line.

Then, take your thumb off the
plunger.

The top of the plunger must
stay lined up with the black dashed Dose Line as you go through the next steps. This will help you get
the correct dose of medicine.

Put aside the syringe with the
needle attached.

IMPORTANT:

It is normal to see a few
bubbles in the mixture. The bubbles will not harm you or affect your dose.

You can inject the medicine
in your stomach area (abdomen), your thigh, or the back of your upper arm.

Each week you can use the same
area of your body but choose a different injection site in that area.

Gently clean the site you
choose with soap and water or an alcohol swab.

Now, pick up the syringe and
hold it near the black dashed Dose Line.

Pull the needle cover
straight off. Do not twist.

Be careful not to push in the
plunger.

When you remove the cover, you
may see 1 or 2 drops of liquid. This is normal.

Insert the needle into your
skin (subcutaneously). To inject your full dose, push down on the plunger with
your thumb until it stops.

Withdraw the needle.

Be sure to use the injection
technique recommended by your healthcare provider.

Disposing of used Needles
and Syringes:

Put your used needles and
syringes in a FDA-cleared sharps disposal container right away after use. Do
not throw away (dispose of) loose needles and syringes in your household
trash.

If you do not have a
FDA-cleared sharps disposal container, you may use a household container that
is:

made of a heavy-duty plastic,

can be closed with a
tight-fitting, puncture-resistant lid, without sharps being able to come out,

upright and stable during use,

leak-resistant, and

properly labeled to warn of
hazardous waste inside the container.

When your sharps disposal container
is almost full, you will need to follow your community guidelines for the right
way to dispose of your sharps disposal container. There may be state or local
laws about how you should throw away used needles and pens. For more
information about safe sharps disposal, and for specific information about
sharps disposal in the state that you live in, go to the FDA's website at:
http://www.fda.gov/safesharpsdisposal.

Please keep these
Instructions for Use for your next dose.

Common Questions and Answers

If your question is about:

See question number:

How soon to inject after mixing

1

Mixing the medicine

2

Air bubbles in syringe

3

Attaching the needle

4

Removing the needle cover

5

Plunger not lining up with black dashed Dose Line

6

Being unable to push the plunger down when injecting

7

1. After I mix the medicine,
how long can I wait before taking the injection?

You must take your injection of
BYDUREON right after mixing it. If you do not inject BYDUREON right away, the
medicine will start to form small clumps in the syringe. These clumps can clog
the needle when you take the injection (see question 7).

2. How do I know that the
medicine is mixed well?

When the medicine is mixed
well, it should look cloudy. There should not be any dry powder on the sides or
bottom of the vial. If you do see any dry powder, shake hard while
continuing to push down on the plunger with your thumb. (This question
relates to the steps shown on pages X through X.)

3. I'm ready to take the injection. What should I do
if I see air bubbles in the syringe?

It is normal for air bubbles to be in the syringe. The
air bubbles will not harm you or affect your dose. BYDUREON is injected into
your skin (subcutaneously). Air bubbles are not a problem with this type of
injection. (This question relates to step 3f shown on page X and step 4c shown
on page X.)

4. What should I do if I have trouble attaching the
needle?

First, be sure you have removed the blue cap. Then, twist
the needle onto the syringe until snug. To prevent losing medicine, do not push
in the plunger while attaching the needle. (This question relates to step 4a on
page X.)

5. What should I do if I have trouble removing the
needle cover?

With one hand, hold the syringe near the black dashed
Dose Line. With your other hand, hold the needle cover. Pull the needle
cover straight off. Do not twist it. (This question relates to step 4f on
page X.)

6. I am at step 4c. What should I do if the top of the
plunger has been pushed past the black dashed Dose Line?

The black dashed Dose Line shows the correct dose. If the
top of the plunger has been pushed past the line, you should continue from step
4d and take the injection. Before your next injection in 1 week, carefully
review the instructions on pages X through X.

7. When I inject, what should I do if I cannot push
the plunger all the way down?

This means the needle has become clogged. Remove the
needle from your skin and replace it with the spare needle from your tray. Then
choose a different injection site and finish taking the injection.

To review how to:

Remove the blue cap of the needle, see page X

Attach the needle, see page X

Remove the needle cover and give the injection, see pages
X and X

If you still cannot push the plunger all the way down,
remove the needle from your skin. Use a puncture-resistant container to throw
away the syringe with the needle still attached. It is important that you then
call 1-877-700-7365.

To help prevent a clogged needle, always mix the medicine
very well and inject right after mixing.

Where to learn more about BYDUREON

Talk with your healthcare provider

Read the Medication Guide that came with your
BYDUREON. The Medication Guide can help answer your questions about
BYDUREON, such as what it is used for, possible side effects, and when to take
BYDUREON.

Enroll in BYDUREON Support for FREE ongoing help managing
your diabetes. Visit www.BYDUREON.com or call 1-877-700-7365.

These Instructions for Use have been approved by the U.S.
Food and Drug Administration.

Before using Bydureon Pen, your
healthcare provider should show you how to use it the right way.

Read the Instructions for
Use before you start using Bydureon Pen and each time you get a refill. There may be new
information. This information does not take the place of talking to your
healthcare provider about your medical condition or your treatment.

Getting ready

Never share your Bydureon
Pen or needles with anyone else. You may give an infection to them or get an
infection from them.

Bydureon Pen is not for
self-injection by people who are blind or cannot see well.

To get your full dose the
medicine must be mixed well. If it's not mixed well, tap longer and more
firmly.

Check the Bydureon mix
again.

Compare both sides of the
mixing window to the photos below by holding your Pen against the page. Pay attention to the bottom
surface. If you do not see clumps you are ready to inject (see
Figure C).

Figure C

If you have any questions or are not sure if your
Bydureon is mixed well, call 1-877-700-7365 for help.

Step 3: Inject your dose

IMPORTANT: After the
medicine is mixed well, you must inject your dose right away. You cannot save it for
later use. Choose your injection site.

The recommended injection sites
for Bydureon are your stomach (abdomen), thigh, or back of the arm.

Each week you can use the same area
of your body but choose a different injection site in that area.

Gently wipe the site you choose
with an alcohol swab (not included).

Twist knob to release
injection button.

Hold your Pen with the
needle pointing straight up and turn the white knob until the orange label
disappears and the injection button is released. DO NOT push the
injection button yet.

Remove the needle cover.

Pull the needle cover straight
off. DO NOT twist the needle cover.

You may see a few drops of
liquid on the needle or in the cover.

Inject your Bydureon.

Insert the needle into your
skin.

Press the injection button with
your thumb until you hear a “click.” Keep holding the button down and slowly
count to 10 to get your full dose.

Properly dispose of your
Pen.

Put your used needles and Pens
in an FDA-cleared sharps disposal container right away after use. Do not
throw away (dispose of) loose needles and Pens in your
household trash. See Common Questions and Answers for additional
disposal information.

Common Questions and
Answers:

1. How do I know that the
Bydureon is mixed well?

The Bydureon is mixed well when
the liquid looks cloudy from both sides of the window. You should not see any
clumps in the liquid. It may help to hold your Pen up to the light to see in
the window. If you see clumps of any size keep tapping your Pen firmly against
the palm of your hand until mixed.

2. I am having trouble
mixing my dose. What should I do?

Remember, before preparing your
dose, leave your Pen out of the refrigerator for at least 15 minutes. This will
let your Pen warm up to room temperature. It will be easier to mix Bydureon if
your Pen is at room temperature.

Be sure you are holding your Pen
at the end with the knob and the orange label. This will help you grip your Pen
better and tap it more firmly against your palm.

It may also help to tap the
mixing window on both sides against your palm. If you see any clumps, keep
tapping.

3. After I mix Bydureon, how
long can I wait before taking the injection?

You must inject your dose of
Bydureon right after mixing it. If you do not inject your Bydureon right away,
small clumps of medicine may form in your Pen and you may not get your full
dose.

4. I am ready to inject my
dose. What should I do if I see air bubbles in the Pen?

It is normal for air bubbles to
be in your Pen. Bydureon is injected into your skin (subcutaneously). Air
bubbles will not harm you or affect your dose with this type of injection.

5. What should I do if I cannot push the injection
button all the way in when trying to inject my dose?

Check that you have fully screwed on the pen needle. Also
be sure you twisted the knob until it stopped, the orange label disappeared,
and the injection button appears.

If you still cannot push the button in, this may mean
that the needle is clogged. Remove the needle from your skin and replace it
with the spare needle from the carton. Review how to attach the needle. Then
choose a different injection site and finish taking the injection.

If you still cannot push the button all the way in,
remove the needle from your skin. Use a puncture-resistant container to throw
away the pen with the needle still attached.

If you have problems giving your Bydureon Pen injection
or have any questions call 1-877-700-7365 for more instructions.

6. How do I know if I injected my full dose?

To be sure you get your full dose, press the injection
button with your thumb until you hear a “click.” After the “click,” continue to
hold the needle in your skin for 10 seconds. This will allow enough time for
you to get your full dose.

If you do not have an FDA-cleared sharps disposal
container, you may use a household container that is:

made of a heavy-duty plastic,

can be closed with a tight-fitting, puncture-resistant
lid, without sharps being able to come out,

upright and stable during use,

leak-resistant, and

properly labeled to warn of hazardous waste inside the
container.

When your sharps disposal container is almost full, you
will need to follow your community guidelines for the right way to dispose of
your sharps disposal container. There may be state or local laws about how you
should throw away used needles and Pens. For more information about safe sharps
disposal, and for specific information about sharps disposal in the state that
you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

This Instructions for Use has
been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 6/9/2014
This monograph has been modified to include the generic and brand name in many instances.